SM Biomed Sdn Bhd – FDA 483, Mar 23, 2018
An FDA inspection of SM Biomed Sdn. Bhd. in Sungai Petani, Malaysia, revealed a significant issue regarding the validation of a printer used for imprinting critical information onto API templates. The firm lacked documented evidence that the specific printer in use had been validated, with a discrepancy noted between the validated printer's identification and the printer actually utilized. This indicates a potential control weakness in their labeling process for active pharmaceutical ingredients.
ID · e8e62394-9a21-453b-b51c-94b675170951
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